Safety and Efficacy of Cariprazine in Patients With Schizophrenia
Schizophrenia
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Acute Schizophrenia, Psychotropic Drugs, Aripiprazole, Antipsychotic Agents, Mental Disorders, Dopamine Agents, Central Nervous System Agents
Eligibility Criteria
Inclusion Criteria:
- Patients who have provided informed consent prior to any study specific procedures
- Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID)
- Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)
- Current psychotic episode (schizophrenia exacerbation) < 2 weeks duration at Visit 1
- Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120
- CGI-S score ≥ 4
Exclusion Criteria:
- Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders
- Bipolar I and II disorder
- Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders
- DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study
- Women who are pregnant or breast feeding
Sites / Locations
- Woodland International Research Group, Inc.
- Woodland Research Northwest, LLC
- Synergy Clinical Research of Escondido
- Excell Research, Inc
- Clinical Innovations, Inc.
- Sharp Mesa Vista Hospital
- Collaborative Neuroscience Network, Inc.
- Colorado Clinical Trials, Inc.
- Comprehensive Clinical Development, Inc.
- Florida Clinical Research Center, LLC
- Hawaii Clinical Research Center
- Uptown Research Institute, LLC
- Alexian Brothers Center for Psychiatric Research
- Precise Research Centers
- Millennium Psychiatric Associates, LLC
- CRI Worldwide, LLC
- Windsor-Laurelwood Center for Behavioral Medicine
- Vanderbilt Psychiatric Hospital
- Claghorn-Lesem Research Clinic, Ltd.
- Pacific Institute of Medical Sciences
- Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Clinica X Psihiatrie
- Spitalul Clinic de Psihiatrie 'Prof. Dr. Alexandru Obregia', Clinica III Psihiatrie
- Spitalul Clinic de Psihiatrie 'Prof. Dr. Alexandru Obregia', Clinica VIII Psihiatrie
- Spitalul Clinic Judetean de Urgenta Cluj, Clinica de Psihiatrie III
- Spitalul Clinic de Neuropsihiatrie Craiova, Clinica II Psihiatrie
- Spitalul Clinic Militar de Urgenta, 'Dr. Stefan Odobleja' Clinical de Psihiatrie
- Spitalul Judetean de Urgenta Piatra Neamt
- Spitalul Judetean de Urgenta Pitesti, Clinica de Psihiatrie
- Spitalul de Psihiatrie Dr. Gheorghe Preda" Sibiu
- Spitalul Judetean de Urgenta Targoviste, Sectia Psihiatrie
- Spitalul Clinic Judetean Mures, Clinica Psihiatrie I
- Spitalul Clinic Judetean de Urgenta Timisoara, Sectia Clinica de Psihiatrie "eduard Pamfil"
- Healthcare Institution "Moscow Regional Mental Hospital #5"
- State Healthcare Institution <Arkhangelsk Regional Clinical Psychiatric Hospital>
- State Healthcare Institution "Regional Clinical Specialized Psychoneurological Hospital #1"
- State Educational Institution of High Professional Education "Chita State Medical Academy of Roszdrav"
- St. Petersburg State Healthcare Institution "Mental Hospital #1 named after P.P Kashchenko"
- Municipal Healthcare Institution "City Clinical Hospital #2 named after V.I Razumovsky"
- State Healthcare Institution "Saratov Saint Sophia Regional Mental Hospital"
- St. Petersburg State Healthcare Institution "St. Nicholas the Wonderworker Mental Hospital"
- Federal State Budget Institution "St. Petersburg scientific-research psychoneurological Institute named after V.M Bekhterev" of the Ministry of Health and Social Development of the Russian Federation, Department of biological therapy of mental patients
- State institution "St. Petersburg scientifis-research psychoneurologic Institute of RosZdrav named after V.M Bekhterev"
- Federal State Budget Institution "St. Petersburg scientific-research psychoneurological Institute named after V.M Bekhterev" of the Minitstry of Health and Social Development of the Russian Federation
- St. Petersburg State Healthcare Institution "City Mental Hospital #6 (hospital and Dispensary)"
- St. Petersburg State Healthcare Institution "City Mental Hospital #3 named after I.I Skvortsov-Stepanov", department #7
- Regional State Healthcare Institution "Tomsk Clinical Mental Hospital"
- Communal Institution of Kyiv Regional Council: Regional Psychiatric-Narcological Medical Association, Department #2 and #14
- I.I. Mecnikov Regional Clinical Hospital, Regional Center of Psychosomatic Pathology
- Ukraine State Scientific and Research Institute of Medical and Social Problems of Disabiolity, Department of Psychoneurology, Psychotherapy and Medical Psychology
- Regional Clinical Psychiatric Hospital Department #11, M. Gorkyy Donetsk National Medical University, Chair of Psychiatry and Medical Psychology
- Kharkiv Regional Clinical Psychiatric Hospital #3, Department #4, Department #14
- State Institution: Institute of Neurology, Psychiatry and Narcology of the AMS of Ukraine, Department of Borderline Psychic Pathology
- Kherson Regional Psychiatric Hospital, Department #3
- Kyiv City Clinical Psychoneurological Hospital #1, Center of Novel Treatment Methods and Rehabilitation of Psychotic Conditions
- Communal Institution: Lviv Regional Clinical Psychiatric Hospital, Department #3 (male), Department #10 (female)
- O.F. Maltsev Poltava Regional Clinical Psychiatric Hopspital, Department #3B, State Institution of Higher Education of Ukraine: Ukranian Medical Stomatological Academy, Chair of Psychiatry, Narcology and Medical Psychology
- Crimean Republican Institution: Clinical Psychiatric Hospital #1, Female Psychiatric Department #2, Male Psychiatric Department #1, S.I. Georgiyevskyy Crimean State Medical University, Chair of Psychiatry, Psychotherapy and Narcology
- O.I. Yuschenko Vinnytsya Regional Psychoneurological Hospital, Department #10, Department #14, M.I. Pyrogov Vinnytsya National Medical University, Chair of Psychiatry and Narcology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Active Comparator
Placebo Comparator
Cariprazine 3mg
Cariprazine 6mg
Aripiprazole 10mg
Placebo
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Patients who meet eligibility criteria will be administered a once daily oral dose of aripiprazole for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.